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Addressing Both Depression and Pain in Late Life: The Methodology of the ADAPT Study

Identifieur interne : 000E97 ( Istex/Corpus ); précédent : 000E96; suivant : 000E98

Addressing Both Depression and Pain in Late Life: The Methodology of the ADAPT Study

Auteurs : Jordan F. Karp ; Bruce L. Rollman ; Charles F. Reynolds Iii ; Jennifer Q. Morse ; Frank Lotrich ; Sati Mazumdar ; Natalia Morone ; Debra K. Weiner

Source :

RBID : ISTEX:3E5EC73D35DD904BB07F0AEC0C6FBD92E71DC96B

English descriptors

Abstract

Objective.  To describe the methodology of the first NIH‐funded clinical trial for seniors with comorbid depression and chronic low back pain.

Url:
DOI: 10.1111/j.1526-4637.2011.01322.x

Links to Exploration step

ISTEX:3E5EC73D35DD904BB07F0AEC0C6FBD92E71DC96B

Le document en format XML

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<div type="abstract">Objective.  To describe the methodology of the first NIH‐funded clinical trial for seniors with comorbid depression and chronic low back pain.</div>
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Randomized controlled effectiveness trial using stepped care methodology. Participants are ≥60 years old. Phase 1 (6 weeks) is open treatment with venlafaxine xr 150 mg/day and supportive management (SM). Response is 2 weeks of PHQ‐9 ≤5 and at least 30% improvement in the average numeric rating scale for pain. Nonresponders progress to phase 2 (14 weeks) in which they are randomized to high‐dose venlafaxine xr (up to 300 mg/day) with problem solving therapy for depression and pain (PST‐DP) or high‐dose venlafaxine xr and continued SM. Primary outcomes are the univariate pain and depression response and both observed and self‐reported disability. Survival analytic techniques will be used, and the clinical effect size will be estimated with the number needed to treat. We hypothesize that self‐efficacy for pain management will mediate response for subjects randomized to venlafaxine xr and PST‐DP.</p>
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Not applicable.</p>
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The results of this trial will inform the care of these complex patients and further understanding of comorbid pain and depression in late life.</p>
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<b>Objective. </b>
To describe the methodology of the first NIH‐funded clinical trial for seniors with comorbid depression and chronic low back pain.</p>
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<b>Methods. </b>
Randomized controlled effectiveness trial using stepped care methodology. Participants are ≥60 years old. Phase 1 (6 weeks) is open treatment with venlafaxine xr 150 mg/day and supportive management (SM). Response is 2 weeks of PHQ‐9 ≤5 and at least 30% improvement in the average numeric rating scale for pain. Nonresponders progress to phase 2 (14 weeks) in which they are randomized to high‐dose venlafaxine xr (up to 300 mg/day) with problem solving therapy for depression and pain (PST‐DP) or high‐dose venlafaxine xr and continued SM. Primary outcomes are the univariate pain and depression response and both observed and self‐reported disability. Survival analytic techniques will be used, and the clinical effect size will be estimated with the number needed to treat. We hypothesize that self‐efficacy for pain management will mediate response for subjects randomized to venlafaxine xr and PST‐DP.</p>
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<p>Supported by grant AG033575 (Karp) and by grant KL2 RR024154 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. The content is solely the responsibility of the authors and does not necessarily represent the official view of NCRR or NIH. Medications were provided by Pfizer for this investigator initiated trial.</p>
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<p>Potential Conflicts of Interest: Dr. Karp served on advisory boards for Eli Lilly and Theravance greater than 1 year ago. He has received medication supplies for investigator initiated research from Pfizer, Eli Lilly, and Reckitt Benckiser. He owns stock in Corcept. Dr. Reynolds has received medication supplies for investigator initiated research from Eli Lilly, Pfizer, Forest, and Bristol Myers. The other authors do not declare any potential conflict of interest.</p>
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<title>Addressing Both Depression and Pain in Late Life: The Methodology of the ADAPT Study</title>
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<title>ADAPT Depression and Pain in Seniors</title>
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<title>Addressing Both Depression and Pain in Late Life: The Methodology of the ADAPT Study</title>
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<name type="personal">
<namePart type="given">Jordan F.</namePart>
<namePart type="family">Karp</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>Departments of Psychiatry</affiliation>
<affiliation>Anesthesiology</affiliation>
<affiliation>E-mail: karpjf@upmc.edu</affiliation>
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<name type="personal">
<namePart type="given">Bruce L.</namePart>
<namePart type="family">Rollman</namePart>
<namePart type="termsOfAddress">MD, MPH</namePart>
<affiliation>Departments of Psychiatry</affiliation>
<affiliation>Medicine</affiliation>
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</name>
<name type="personal">
<namePart type="given">Charles F.</namePart>
<namePart type="family">Reynolds III</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>Departments of Psychiatry</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">Jennifer Q.</namePart>
<namePart type="family">Morse</namePart>
<namePart type="termsOfAddress">PhD</namePart>
<affiliation>Departments of Psychiatry</affiliation>
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<roleTerm type="text">author</roleTerm>
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<name type="personal">
<namePart type="given">Frank</namePart>
<namePart type="family">Lotrich</namePart>
<namePart type="termsOfAddress">MD, PhD</namePart>
<affiliation>Departments of Psychiatry</affiliation>
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<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">Sati</namePart>
<namePart type="family">Mazumdar</namePart>
<namePart type="termsOfAddress">PhD</namePart>
<affiliation>Departments of Psychiatry</affiliation>
<affiliation>Biostatistics, University of Pittsburgh and University of Pittsburgh School of Medicine</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">Natalia</namePart>
<namePart type="family">Morone</namePart>
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<affiliation>Medicine</affiliation>
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<name type="personal">
<namePart type="given">Debra K.</namePart>
<namePart type="family">Weiner</namePart>
<namePart type="termsOfAddress">MD</namePart>
<affiliation>Departments of Psychiatry</affiliation>
<affiliation>Anesthesiology</affiliation>
<affiliation>Medicine</affiliation>
<affiliation>Geriatric Research Education and Clinical Center, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA</affiliation>
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<dateIssued encoding="w3cdtf">2012-03</dateIssued>
<copyrightDate encoding="w3cdtf">2012</copyrightDate>
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<abstract>Objective.  To describe the methodology of the first NIH‐funded clinical trial for seniors with comorbid depression and chronic low back pain.</abstract>
<abstract>Methods.  Randomized controlled effectiveness trial using stepped care methodology. Participants are ≥60 years old. Phase 1 (6 weeks) is open treatment with venlafaxine xr 150 mg/day and supportive management (SM). Response is 2 weeks of PHQ‐9 ≤5 and at least 30% improvement in the average numeric rating scale for pain. Nonresponders progress to phase 2 (14 weeks) in which they are randomized to high‐dose venlafaxine xr (up to 300 mg/day) with problem solving therapy for depression and pain (PST‐DP) or high‐dose venlafaxine xr and continued SM. Primary outcomes are the univariate pain and depression response and both observed and self‐reported disability. Survival analytic techniques will be used, and the clinical effect size will be estimated with the number needed to treat. We hypothesize that self‐efficacy for pain management will mediate response for subjects randomized to venlafaxine xr and PST‐DP.</abstract>
<abstract>Results.  Not applicable.</abstract>
<abstract>Conclusions.  The results of this trial will inform the care of these complex patients and further understanding of comorbid pain and depression in late life.</abstract>
<subject lang="en">
<genre>keywords</genre>
<topic>Clinical Trial</topic>
<topic>Geriatrics</topic>
<topic>Depression</topic>
<topic>Back Pain</topic>
<topic>Survival Analysis</topic>
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<identifier type="ISSN">1526-2375</identifier>
<identifier type="eISSN">1526-4637</identifier>
<identifier type="DOI">10.1111/(ISSN)1526-4637</identifier>
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<part>
<date>2012</date>
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<caption>vol.</caption>
<number>13</number>
</detail>
<detail type="issue">
<caption>no.</caption>
<number>3</number>
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<start>405</start>
<end>418</end>
<total>14</total>
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<identifier type="ark">ark:/67375/WNG-3N6D7655-3</identifier>
<identifier type="DOI">10.1111/j.1526-4637.2011.01322.x</identifier>
<identifier type="ArticleID">PME1322</identifier>
<accessCondition type="use and reproduction" contentType="copyright">Wiley Periodicals, Inc.</accessCondition>
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